UMIN ID: C000000354
Registered date:10/03/2006
Dose finding study of Campath-1H in haploidentical HLA-mismatched hematopoietic stem cell transplantation for hematological malignancies
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hematological malignancies |
| Date of first enrollment | 2005/04/01 |
| Target sample size | 36 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | To find minimum tolerated dose by reducing the dose of Campath-1H with evaluation of the incidence of grade III to IV acute GVHD. |
Outcome(s)
| Primary Outcome | Donor cell engraftment and the incidence of grade III to IV acute GVHD within 60 days after transplantation |
|---|---|
| Secondary Outcome | Relapse rate and non-relapse mortality at 1 year Overall survival at 1 year Immune reconstitution |
Key inclusion & exclusion criteria
| Age minimum | 16years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients who have an available HLA-A/B/DR-matched or 1-locus-mismatched donor in family members. 2. Patients who have an HLA-matched unrelated donor and whose disease status can wait for time-consuming donor coordination. |
Related Information
| Primary Sponsor | University of Tokyo Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshinobu Kanda |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| ycanda-tky@umin.ac.jp | |
| Affiliation | University of Tokyo Hospital Department of Hematology & Oncology |
| scientific contact | |
| Name | Yoshinobu Kanda |
| Address | 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| Affiliation | University of Tokyo Hospital Department of Hematology & Oncology |